El ISAR PLASTER, estudio en fase 2, evaluó el Revacept, una proteína monoclonal que inhibe la GPVI en pacientes con angioplastia coronaria programada. La agregación plaquetaria es un factor clave del proceso de trombosis que ocurre en el contexto del accidente de placa u oclusión de un stent coronario. La plaqueta sufre dos procesos consecutivos
El ISAR PLASTER, estudio en fase 2, evaluó el Revacept, una proteína monoclonal que inhibe la GPVI en pacientes con angioplastia coronaria programada.
La agregación plaquetaria es un factor clave del proceso de trombosis que ocurre en el contexto del accidente de placa u oclusión de un stent coronario. La plaqueta sufre dos procesos consecutivos para colaborar en la formación del trombo: el primero, que se denomina activación plaquetaria, lleva a la expresión de los receptores que permiten la unión de una plaqueta con otra, y el segundo, llamado agregación plaquetaria que consiste finalmente en dicha unión.
La inhibición de este proceso tiene impacto en la reducción de eventos clínicos que sufren los pacientes. Hasta el día de hoy, esta inhibición se ha logrado con fármacos que actúan directamente sobre distintos objetivos plaquetarios: 1) producción de tromboxano, con la aspirina, 2) receptores de ADP (P2Y12) con clopidogrel, ticagrelor, prasugrel o cangrelor 3) receptores de fibrinógeno (IIbIIIa) con tirofibán, eptifibitide y abxicimab 4) receptor de trombina (PAR-1) con Vorapaxar. Todos estos mecanismos tienen en común bloquear la agregación plaquetaria de forma continua, y de esta manera afectar la hemostasia sistémica, traduciendo esto último en un mayor riesgo de sangrado.
El propósito de lograr inhibir el proceso de agregación plaquetaria potentemente sin aumentar el riesgo hemorrágico ha llevado a la búsqueda de otros objetivos terapéuticos. Si pudiéramos actuar sobre los activadores de las plaquetas y no sobre ellas, hipotéticamente no afectaríamos la hemostasia general.
Uno de los principales factores que llevan a la activación plaquetaria es el colágeno. Las fibras de colágeno representan el componente con mayor poder protrombótico de las placas ateroscleróticas, y al ser expuestas por la erosión o rotura de la capa protectora, se unen al receptor plaquetario denominado glicoproteína VI (GPVI) favoreciendo la activación plaquetaria. Este fenómeno impresiona ser central en los procesos de infarto de miocardio y accidente cerebrovascular, pero menos relevante en la hemostasia fisiológica.
En los últimos años se ha puesto énfasis en el desarrollo de moléculas que actúen sobre este “target” terapéutico, aspirando a que sólo se afecte la agregación plaquetaria a nivel del sitio de rotura de la placa, y de esta manera se reducirían los eventos hemorrágicos asociados. Revacept es una proteína monoclonal que inhibe la GPVI y se administra por vía endovenosa. ACT017 es un anticuerpo monoclonal contra la GPVI. En el estudio ISAR PLASTER, recientemente publicado en JAMA, 334 pacientes sometidos en forma programada a una angioplastia coronaria fueron tratados con revacept 80 mg, revacept 160 mg o placebo añadido al tratamiento médico basado en aspirina y clopidogrel. El estudio tuvo como punto final la reducción de la mortalidad o los infartos periprocedimientos, sin encontrar diferencias en ellos. El punto final de seguridad de sangrados BARC 2 o más no se modificó entre los grupos. El estudio fue un fase 2 y pese a no alcanzar un “pretencioso” punto final primario, demostró la seguridad de la droga al no aumentar los eventos hemorrágicos significativos. El próximo paso es el inicio de estudios en pacientes con síndromes coronarios agudos o con alto riesgo de sufrirlos para poner a prueba la hipótesis de protección de eventos.
En conclusión, el receptor glicoproteíco VI luce como un interesante objetivo terapéutico, atractivo por la posibilidad de inhibir la agregación en lugares específicamente necesarios sin afectar la hemostasia general del paciente. Los próximos años serán claves para evaluar si el revacept u otro medicamento de la familia aportan utilidad en la práctica clínica.
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Lecturas recomendadas
1-Mayer K, Hein-Rothweiler R, Schüpke S et al. Efficacy and Safety of Revacept, a Novel Lesion-Directed Competitive Antagonist to Platelet Glycoprotein VI, in Patients Undergoing Elective Percutaneous Coronary Intervention for Stable Ischemic Heart Disease: The Randomized, Double-blind, Placebo-Controlled ISAR-PLASTER Phase 2 Trial. JAMA Cardiol. 2021 Mar 31:e210475.
2-Beziere N, Fuchs K, Maurer A et al. Imaging fibrosis in inflammatory diseases: targeting the exposed extracellular matrix. 2019 Apr 13;9(10):2868-2881.
3-Borst O, Gawaz M. Glycoprotein VI – novel target in antiplatelet medication. Pharmacol Ther. 2021 Jan;217:107630.
21 comments
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